BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 16243998 · Received January 25, 2023

    Report

    Report Number
    2124215-2023-02586
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT - AWARE DATE OF 19JAN2023 USED AS EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS COMPLETED USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THREE SEPARATE CLOSURE DEVICES WERE ATTEMPTED, AND THE THIRD DEVICE WAS SUCCESSFULLY IMPLANTED. ONE DAY POST INDEX PROCEDURE THE PATIENT WAS DISCHARGED. THE PATIENT THEN PRESENTED TO THE EMERGENCY DEPARTMENT WITH UNSPECIFIED STROKE-LIKE SYMPTOMS. CHEST COMPUTED TOMOGRAPHY WAS PERFORMED WITH NO DEVICE RELATED CONCERNS. THE PATIENT EXPERIENCED SEVERE NOSE BLEEDS AND GASTROINTESTINAL DISTRESS. NO FURTHER INFORMATION ON THE STATUS OF THE PATIENT IS CURRENTLY AVAILABLE. IT WAS FURTHER REPORTED THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH EPISTAXIS, LIGHT HEADEDNESS, AND DIZZINESS. MAGNETIC RESONANCE IMAGING RULED OUT THE OCCURRENCE OF A CVA BUT DID NOT RULE OUT THE OCCURRENCE OF A TRANSIENT ISCHEMIC ATTACK. THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT) WITH A HISTORY OF EPISTAXIS AND BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS COMPLETED USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THREE SEPARATE CLOSURE DEVICES WERE ATTEMPTED, AND THE THIRD DEVICE WAS SUCCESSFULLY IMPLANTED. ONE DAY POST INDEX PROCEDURE THE PATIENT WAS DISCHARGED. THE PATIENT THEN PRESENTED TO THE EMERGENCY DEPARTMENT WITH UNSPECIFIED STROKE-LIKE SYMPTOMS. CHEST COMPUTED TOMOGRAPHY WAS PERFORMED WITH NO DEVICE RELATED CONCERNS. THE PATIENT EXPERIENCED SEVERE NOSE BLEEDS AND GASTROINTESTINAL DISTRESS. NO FURTHER INFORMATION ON THE STATUS OF THE PATIENT IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177095 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0030418350 08714729860518

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other| H